Back to resultsRandomized Trial Comparing Early "Trigger" Versus Delayed "Trigger" Timing in Cycles of Controlled Ovarian Stimulation.
Primary Purpose
Infertility, Female
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ovulatory trigger timing
Sponsored by
About this trial
This is an interventional treatment trial for Infertility, Female
Eligibility Criteria
Inclusion Criteria:
- Adult female at least 18 years of age and less than 35 years of age intending to undergo ovarian stimulation for a cycle of IVF with all embryos to be frozen that attain the blastocyst stage.
- Anticipated at least normal ovarian response evidenced by at least 8 antral follicles observed on ultrasound or a serum level of at least 1.5 ng/ml AMH.
- Ability read and understand English sufficiently to obtain informed consent.
- Patients with prior IVF cycles are allowed, but no patient can undergo more than one cycle with oocyte collection under this study.
Exclusion Criteria:
- Any cycle type that would preclude immediate culture to blastocyst stage (e.g. oocyte banking).
- Any condition that, in the opinion of the physician or principal investigator, would place the patient at undue risk under this protocol or would otherwise make the protocol inappropriate for that subject.
Sites / Locations
- Fertility center of Las VegasRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Early Trigger
Delayed trigger
Arm Description
Outcomes
Primary Outcome Measures
Good-quality blastocysts
Number of blastocysts with A or B morphological grade.
Delayed blastocyst formation
Proportion of good-quality of blastocysts that formed after day 5.
Secondary Outcome Measures
Full Information
NCT ID
NCT05498350
First Posted
August 10, 2022
Last Updated
August 10, 2022
Sponsor
Fertility Center of Las Vegas
1. Study Identification
Unique Protocol Identification Number
NCT05498350
Brief Title
Randomized Trial Comparing Early "Trigger" Versus Delayed "Trigger" Timing in Cycles of Controlled Ovarian Stimulation.
Official Title
Randomized Trial Comparing Early "Trigger" Versus Delayed "Trigger" Timing in Cycles of Controlled Ovarian Stimulation.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 10, 2022 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
November 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fertility Center of Las Vegas
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This randomized trial will compare the efficacy of two different times of administration of medications for final oocyte maturation, commonly called a "trigger", in cycles of controlled ovarian stimulation (COS) for cycles in which all embryos will be cryopreserved ("freeze-all cycles").
Detailed Description
This randomized trial will compare the efficacy of two different times of administration of medications for final oocyte maturation, commonly called a "trigger", in cycles of controlled ovarian stimulation (COS) for cycles in which all embryos will be cryopreserved ("freeze-all cycles").
The early trigger timing will be based on sonographic observation of at least three follicles reaching at least 17mm in diameter.
The delayed trigger timing will be based on at least three follicles reaching at least 22mm in diameter.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Female
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Early Trigger
Arm Type
Experimental
Arm Title
Delayed trigger
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Ovulatory trigger timing
Intervention Description
Timing of medication to induce final oocyte maturation
Primary Outcome Measure Information:
Title
Good-quality blastocysts
Description
Number of blastocysts with A or B morphological grade.
Time Frame
Within 7 days of oocyte retrieval
Title
Delayed blastocyst formation
Description
Proportion of good-quality of blastocysts that formed after day 5.
Time Frame
Within 7 days of oocyte retrieval
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
34 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Adult female at least 18 years of age and less than 35 years of age intending to undergo ovarian stimulation for a cycle of IVF with all embryos to be frozen that attain the blastocyst stage.
Anticipated at least normal ovarian response evidenced by at least 8 antral follicles observed on ultrasound or a serum level of at least 1.5 ng/ml AMH.
Ability read and understand English sufficiently to obtain informed consent.
Patients with prior IVF cycles are allowed, but no patient can undergo more than one cycle with oocyte collection under this study.
Exclusion Criteria:
Any cycle type that would preclude immediate culture to blastocyst stage (e.g. oocyte banking).
Any condition that, in the opinion of the physician or principal investigator, would place the patient at undue risk under this protocol or would otherwise make the protocol inappropriate for that subject.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Forest Garner, MS
Phone
7022541777
Ext
264
Email
Forest@fertilitycenterlv.com
Facility Information:
Facility Name
Fertility center of Las Vegas
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89117
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shironda Anderson, BA
Phone
702-254-1777
Ext
265
Email
Shironda@fertilitycenterlv.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Randomized Trial Comparing Early "Trigger" Versus Delayed "Trigger" Timing in Cycles of Controlled Ovarian Stimulation.
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